Johnson & Johnson continues to face a growing number of product liability lawsuits involving Invokana, a Type 2 diabetes drug allegedly associated with several serious side effects, including diabetic ketoacidosis, kidney damage, heart attack, and stroke.
In an August 3rd filing with the U.S. Securities and Exchange Commission (SEC), Johnson & Johnson acknowledged that at least 800 Invokana lawsuits were pending in state and federal courts throughout the nation. That figure includes some 440 cases that have been centralized in federal multidistrict litigation currently underway in the U.S. District Court, District of New Jersey. Additional federal claims are pending in the Southern District of California and the Eastern District of Missouri.
Cases have also been filed in various state courts around the country, including Pennsylvania, California and New Jersey, while several Invokana class action lawsuits are pending in Canada.
According to the SEC filing, Johnson & Johnson “continues to receive information with respect to potential costs and the anticipated number of cases.” The company has established an accrual for defense costs in connection with the Invokana litigation.
Invokana (canagliflozin) was the first of new class of Type 2 diabetes drugs called SGLT2 inhibitors. Launched in March 2013, the medication lowers blood sugar by inhibiting the absorption of glucose by the kidneys, thus allowing for its elimination via urine. Other SGLT2 inhibitors that have since been approved for sale in the U.S. include Invokamet (canagliflozin and metformin), Farxiga, Xigduo XR, Jardiance, Glyxambi, and Synjardi.
According to Johnson & Johnson’s latest earnings report, international sales of Invokana grew by $4 million to $39 million in the second quarter. However, U.S. sales fell 26.4% to $256 million. For the year, Invokana sales are down 22% domestically.
Since their launch, the side effects potentially associated with Invokana and other SGLT2 inhibitors have prompted U.S. Food & Drug Administration (FDA) to issue a number of safety alerts and order updates to their prescribing information. In May 2015, for example, the agency ordered the drugs’ manufacturers to update their product labels to note a potential risk of diabetic ketoacidosis, a dangerous condition that can lead to diabetic coma or death. At the time, the labels were also modified to warn of serious urinary tract infections that could result in hospitalization.
Last June, the FDA ordered the manufacturers of several SGLT2 inhibitors, including Invokana, Invokamet, Farxiga and Xigduo XR, to strengthen warnings on potential kidney side effects, after the drugs were implicated in more than 100 reports of acute renal injury.
This past May, the prescribing information for Invokana and Invokamet was modified with a new black box warning regarding a risk of leg and foot amputations. A black box is the FDA’s most urgent safety notice, and is reserved for the very serious or life-threatening side effects.